NINDS Biotechnology Products and Biologics Regulatory Affairs Consulting Services STATEMENT OF WORK FINAL REVISED DOCUMENT 04/11/2016 BACKGROUND The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. NINDS intramural labs are headed by federal employees who work for the Institute, primarily located in Bethesda, MD. For more information on the NINDS Intramural program visit the website http://dir1.ninds.nih.gov/ninds/Home.aspx For extramural research, NINDS awards grants and cooperative agreements to outside academic institutions, small business concerns and other organizations all over the U.S. and world to fund promising basic, translational, and clinical research projects. Specifically, the NINDS Office of Translational Research (OTR) is committed to facilitate the translation of basic discoveries into the development of new therapeutic interventions through early nonclinical development and early clinical investigation. For more information about the Office of Translational Research visit the website http://www.ninds.nih.gov/funding/areas/translational_research/index.htm Projects that are funded through a cooperative agreement award mechanism are led by the principal investigators (PI) team with NINDS program staff participation in guiding the project plan. The PI?s team performs all of the experiments while NINDS role is to establish performance milestones for each project to facilitate go/no-go decision making and then monitor research progress and achievement of project milestones. STATEMENT OF OBJECTIVE The NINDS is seeking senior-level, industry-experienced discovery and development Biologics Regulatory Affairs consultants with expertise in biotechnology products and biologics to assist NINDS program staff to vet and advance only the most promising therapeutic biologics through the discovery and development pipeline. Both individual subject matter experts and multidisciplinary teams from consulting firms are encouraged to apply. The NIH anticipates awarding multiple consulting awards in reference to this requirement. Approximately two, and a maximum of three, awards are anticipated. A. SCOPE OF WORK General Requirements Each consultant is expected to provide technical guidance and advice on advancing discovery and development projects through early nonclinical development and submission of an Investigational New Drug (IND) package, and in some cases, design of early clinical protocol and launch of a first in human clinical trial. Consulting services will be for NINDS biologics-focused projects or any other NIH program with similar needs as outlined in the scope of this statement of work. Consulting advice and guidance shall be required to supplement NINDS program experience from the pre-application stage and then throughout the life of each project to review and monitor progress. Consultants will serve as a resource to NINDS staff from the start of early discovery stage projects to structurally modify and optimize design characteristics of leads through IND-enabling activities necessary to advance potential development candidates through scale up, and early phase clinical trials. Consultants will be expected to provide feedback and guidance on projects to NINDS staff through written documents, conference calls, and by email. The consultants? major responsibility will be in offering review, guidance and advice on projects. They will be expected to offer technical review and feedback on project milestones, progress reports, or development plans, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. On rare occasion, consultants may be asked to give oral presentations to NINDS staff or at an NINDS sponsored webinar, workshop or conference to provide training to investigators in their area of expertise. Consultants may be involved in multiple projects. Each project team is led by a PI and supported by NINDS staff with disease and therapy development expertise. The joint team establishes project milestones and monitors progress at least annually. The PIs conduct all of the research activities and report progress to NINDS. NINDS staff will interact directly with the PI and request assistance from consultants to review and provide expert advice on specific topics. Consultants shall directly advise NINDS staff, and in some cases communicate directly with the PI on team calls. Specific Requirements for Biologics Regulatory Affairs Consultants Biologics regulatory affairs consultant shall provide the following services: ? Advise NINDS staff on Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regulatory guidelines, regulations, and requirements pertaining to the early nonclinical and early clinical development of biologics ? Review and assess data and project related proposals, and advise on study requirements to file an IND package for a range of potential biologics therapeutic modalities in nonclinical IND-enabling development ? such as peptides, antibodies, recombinant proteins, oligonucleotides, cell and gene therapies - based on regulatory precedence and compliance to Common Technical Document (CTD) format requirements, including: o Review of administrative information (e.g. target product profiles, clinical protocols, and investigator information) o Review of animal pharmacology and toxicology study results to assess whether the product is expected to be reasonably safe for initial testing in humans o Determine if previous relevant human experience is available for similar biologics or research and report results from relevant clinical trials conducted both inside and outside of the US. o Review chemistry, manufacturing and control (CMC) nonclinical study plans and results pertaining to the composition, manufacturing, testing, stability and controls for a range of biologics to assess compliance to regulatory guidance. o Review clinical protocols and investigator information to assess adherence to investigational regulations and study protocols as it pertains to a biologic modality in each case. o Integrate regulatory guidance with research plans to advance translational research objectives. ? Provide guidance to the preparation of pre-IND and IND Meetings or review FDA responses to recommend new course of action. ? Review, identify and assess regulatory risks and gaps to IND-enabling research study plans and recommend solutions ? Provide oral presentations in area of expertise as requested ? Communicate effectively both orally and in writing B. KEY PERSONNEL The consultants working under this award shall be considered key personnel. Key Personnel requirements are as follows: a) A minimum of an undergraduate degree in a relevant scientific discipline. b) A minimum of 10 years? experience in the biotechnology, pharmaceutical industry or regulatory industry. c) A minimum of 2 years hands-on and in-depth consulting experience in early nonclinical and early clinical development of biologics. The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows: The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty day notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. The following individual(s) is/are considered to be essential to the work being performed here under: Name Title To be determined in the contract award Biologics Regulatory Affairs Consultant Level of Effort The NIH estimates that individual consultants or multidisciplinary teams from consulting firms shall be able to perform the required services. More than one award may be made in relation to this requirement. The estimated level of effort for the overall five year contract is as follows: Overall Contract Requirements (Over 5 Years) Minimum Quantity Maximum Quantity 30 Hours 900 Hours The minimum number of hours shall be guaranteed at time of award. The first task orders issued against the contracts awarded will be for the minimum number of hours (30). Additional hours up to the noted maximum may or may not be added to the award at the Government?s discretion at the award?s negotiated hourly rate. Additional hours shall be ordered via additional task orders against the awarded contracts. Annually, no more than 180 hours may be ordered. The overall contract requirements broken out by contract year are detailed below. Please note that requirements-type contracts do not contain option periods but may contain different pricing for each contract year. August 1, 2016 through July 31, 2017: Minimum of 30 hours up to 180 hours August 1, 2017 through July 31, 2018: Minimum of 0 hours up to 180 hours August 1, 2018 through July 31, 2019: Minimum of 0 hours up to 180 hours August 1, 2019 through July 31, 2020: Minimum of 0 hours up to 180 hours August 1, 2020 through July 31, 2021: Minimum of 0 hour up to 180 hours Ordering and Receiving: The maximum quantity that the Government may order over the life of the IDIQ contract is detailed in the table below. The minimum quantity which may be ordered for the life of the contract is detailed in the same table. Overall Contract Requirements (Over 5 Years) Minimum Quantity Maximum Quantity 30 Hours 900 Hours Orders issued under this contract may be placed in writing or via electronic mail (e-mail) by the authorized designee(s). The authorized designee(s) shall be identified at time of award. The Contractor representative(s) authorized to receive and accept orders shall be identified at time of award. All orders delivered under this contract must be verified by the authorized Federal designee(s). The authorized Federal designee shall formally document all work performed by the Contractor and the Contractor shall assist in this process. Period of Performance This Requirements/Indefinite-Delivery Indefinite-Quantity requirement shall have a period of performance from August 1, 2016 through July 31, 2021. Hourly rates for each year within the period of performance may be separately priced. Should Offeror?s propose different hourly rates for each year, please propose them for the following periods: August 1, 2016 through July 31, 2017 August 1, 2017 through July 31, 2018 August 1, 2018 through July 31, 2019 August 1, 2019 through July 31, 2020 August 1, 2020 through July 31, 2021 Place of Performance The contractor shall provide services remotely from its own site. Government Furnished Property No Government furnished property shall be provided. Travel Under special circumstances, the consultant(s) may be asked to give presentations in their area of expertise to train program staff or investigators. Travel reimbursement will be provided for such presentations. The consultant shall make his/her own travel arrangements in coordination with the Contracting Officer?s Representative (COR). Airplane tickets must be purchased from a US carrier at the coach/economy rate. The Government shall reimburse hotel costs for up to two nights per site visit, as well as food and incidental expenses at the Government per diem rate. All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer?s Representative prior to being finalized or invoiced. Confidential Treatment of Sensitive Information Consultant(s) must guarantee strict confidentiality of the information/data that is provided by the NINDS or by any other participant on a project to which the consultant is assigned. The NINDS has determined that the information/data that the consultant will be provided during the performance of the consulting contract is of a sensitive nature. Consultant(s) may only disclose the information/data generated for a particular project to other participants on that same project. These specific individuals will be identified when the consultant is assigned to a project. Disclosure of the information/data, in whole or in part, by the consultant to anyone else can only be made after the consultant receives prior written approval from the Contracting Officer. Whenever the consultant is uncertain with regard to the proper handling of information/data under the contract, the consultant shall obtain a written determination from the Contracting Officer. Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information. Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service. The consultant may store data up to 12 months after initially receiving it, after that time the consultant should either delete the data files and sanitize the computer using NIST SP 800-88 (current revision) or if information is still needed contact the Contracting Officer Representative and Contracting Officer for approval to store data longer. IT Security Requirements NINDS requires that the consultant?s meet certain minimum IT Security Requirements: All computers that are used by the consultant to perform work under this contract whether contractor furnished or government furnished will have to have: ? Virus protection with regular automated scans ? Up to date security patching ? Two factor authentication ? Encryption - FIPS 140-2 compliant encryption solution ? Regular vulnerability scans and if the scan produces any high or medium results they need to be correction the high within 30 days and the mediums within 90 days. ? Contractors will have to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/. ? Consultant will have to sign the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf ? Report any lost or stolen NIH data to Donna Stephenson, NINDS ISSO 301.496.0368 donna.stephenson@nih.gov within one hour (also notify the Contracting Officer Representative and Contracting Officer) of knowing of the lost or theft even if the data is on a contractor furnished computer. https://ocio.nih.gov/InfoSecurity/IncidentResponse/Pages/scroster.aspx ? Contractors must adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx Please refer to Appendix A for a full list of the IT security requirements. Section 508 Compliance Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies? electronic and information technology (EIT) is accessible to people with disabilities. The Federal Acquisition Regulations (FAR) Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board?s Web site at https://www.access-board.gov/508.htm. Unless it is an ?undue burden? or compliant products or services do not exist, the products must conform to Section 508. The contractor should state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception. NINDS may put contractor?s presentation on its public website. Presentations (video and/or powerpoint ) must allow for individuals with disabilities to view them by following Section 508 accessibility standards from the United States Board 36 CFR Part 1194. Section 508 requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency. For example, presentations should not use color coding as the only means of conveying information, indicating an action, prompting a response, or distinguishing a visual element. In addition, all training and informational video and multimedia productions which support the agency's mission, regardless of format, that contain speech or other audio information necessary for the comprehension of the content, shall be open or closed captioned. Partially conforming presentations will be accepted from the contractor, since the COR will work with the contractor and the NINDS IT Web Team to make contractor?s presentation fully compliant with Section 508. Collaboration It is required that all contractors involved with the NINDS community work collaboratively with federal staff and other contractors towards the NINDS mission and other affected organizations and follow the direction of the Contracting Officer?s Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required. Data Rights The NINDS shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations, briefings, work plans, created SOPs and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of ?unlimited rights? is contained in Federal Acquisition Regulation (FAR) 27.401, ?Definitions.? FAR clause 52.227-14, ?Rights in Data-General,? is hereby incorporated by reference and shall be made a part of any resulting contract/order. Non-Personal Service Statement Contract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR). Evaluation Criteria The Government will award a purchase order resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price and all technical evaluation factors are detailed below: Technical Evaluation Factors Weight Factor 1: Technical Capability The Contractor?s proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. Ability to effectively communicate will be particularly considered. 35 Factor 2: Key Personnel Qualifications Offerors proposals shall be evaluated for level of conformance to the key personnel qualifications identified in this statement of work. Offeror proposals must contain a resume/CV. a) A minimum of an undergraduate degree in a relevant scientific discipline. b) A minimum of 10 years? experience in the biotechnology, pharmaceutical industry or regulatory industry is required. c) A minimum of 2 years hands-on and in-depth consulting experience in early nonclinical and early clinical development of biologics. 10 Factor 3: Past Performance The Contractor shall provide at least two (2) past performance references with knowledge of the contractor?s relevant skills and experience related to the requirements outlined in this Statement of Work. References shall include the following information: a) Name of Organization b) Description of Contractor?s responsibilities as they relate to this SOW c) Contract Period of Performance d) Contact Name and Title e) Telephone Number f) E-mail address Past Performance shall be evaluated as follows: 1) Experience in Early Nonclinical Development and Approach to Providing Expert Review and Advice a) Contractor?s past experience in early nonclinical development of different biologics leading to successful pre-IND meeting outcomes for clients and IND submissions to FDA (CDER and CBER). Contractor is expected to integrate regulatory guidance with research plans to span all aspects of nonclinical development to secure a successful IND package for different biologics. b) Contractor?s approach to providing expert review and advice for regulatory strategy development, early nonclinical product development planning, target product profile development, risk analysis, and regulatory submission strategy for different biologics ? such as peptides, antibodies, recombinant proteins, oligonucleotides, cell and gene therapies. 2) Experience in Enabling Early Clinical Development and Clinical Study Design a) Contractor?s past experience in enabling early clinical development and clinical study design considerations for biologics. b) Contractor experience and knowledge to provide regulatory advice for advanced and/or novel potential biologics-based therapies. 35 20 Technical proposals will be evaluated using a summary adjectival rating based on total numerical score in accordance with the above and the following scale: Excellent (90 ? 100) Very Good (80 ? 89) Good (70 - 79) Fair (60 ? 69) Poor (0-59) Additional Applicable Terms and Conditions FAR 52.227-14 Rights in Data-General (May 2014) is applicable to this requirement. FAR 52.216-18 Ordering (October 1995) is applicable to this requirement. FAR 52.216-19 Order Limitations (October 1995) is applicable this requirement. FAR 52.216-21 Requirements (October 1995) is applicable to this requirement. HHSAR 352.224-70 Privacy Act (December 18, 2015) is applicable to this requirement. HHSAR 352.237-75 Key Personnel (December 18, 2015) is applicable to this requirement. Independent Government Cost Estimate The minimum cost estimated for this five year Indefinite Delivery Indefinite Quantity contract is $7,800.00 and the maximum cost estimated is $257,580.00. This estimate is based on a fully loaded hourly consultant labor rate of $260.00 (with a 3% yearly hourly rate increase) for 180 hours per year during the award period of performance. Contracting Officer Representative Christina Vert, MS 6001 Executive Blvd. Suite 2141B Bethesda, MD 20892-1620, USA E-mail: vertc@nih.gov Telephone: 301-451-9621 The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this purchase order; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this purchase order. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this purchase order; (5) otherwise change any terms and conditions of this purchase order; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in the purchase order. The Government may unilaterally change the COR designation for this purchase order.